Regulatory & Clinical Specialist

About the role

The Regulatory and Clinical Specialist supports the clinical evaluation activities, reviews promotional materials, and assists with regulatory submissions for active implantable medical devices in the Neuromodulation Business Unit.

Responsibilities

• Author, prepare, and/or update clinical evaluation plans (CEP) and reports (CER) for active implantable medical devices/systems in accordance with EU MDR requirements.
• Conduct systematic literature searches, appraisals, analyses, and summaries of data for state-of-the-art, safety, and performance periodically.
• Manage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members.
• Support the Compliance Review Board process by reviewing promotional materials for compliance with applicable regional regulation as the Regulatory representative.
• Maintain a continued awareness and understanding of EU and FDA regulations and guidance documents.
• Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.).
• Directly interface with the Regulatory Agencies on assigned projects.
• Perform regulatory assessments of changes as part of the change management process.
• Work daily with a high level of integrity and promote a diverse and inclusive workplace culture in both people and thought leadership that is consistent with LivaNova values.

Requirements

• Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements.
• Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases.
• Demonstrated experience in the development, writing, and editing of regulatory/clinical submissions (e.g., FDA PMA applications, IDE Progress Reports, technical files).
• Medical writing experience with US and EU regulatory requirements understanding in medical device.
• Class III active-implantable experience, preferred.
• Demonstrates negotiation and conflict resolution skills.
• Demonstrates ability to rapidly learn new therapeutic areas.
• Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.

Skills

• Experience writing Clinical Evaluation Plans and Reports (CEP, CER, respectively) to support EU MDD and MDR requirements.
• Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases.
• Demonstrated experience in the development, writing, and editing of regulatory/clinical submissions (e.g., FDA PMA applications, IDE Progress Reports, technical files).
• Medical writing experience with US and EU regulatory requirements understanding in medical device.
• Class III active-implantable experience, preferred.
• Demonstrates negotiation and conflict resolution skills.
• Demonstrates ability to rapidly learn new therapeutic areas.
• Proven abilities in demonstrating good judgment, building effective working relationships, excellent problem-solving skills.

Qualifications

• Minimum of a master’s degree in biomedical engineering, science or equivalent technical discipline and at least 5 years of previous related experience in medical writing and medical device regulatory affairs or a Ph.D. with at least 3 years of experience.

Pay

A reasonable estimate of the annual base salary for this position is $85,000 - $95,000 plus discretionary annual bonus. Pay ranges may vary by location.

Benefits

• Health benefits – Medical, Dental, Vision
• Personal and Vacation Time
• Retail and Savings Plan (401K)
• Employee Stock Purchase Plan
• Training & Education Assistance
• Bonus Referral Program
• Service Awards
• Employee Recognition Program
• Flexible Work Schedules

Notice To Third Party Agencies

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee.